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阿立哌唑单药及辅助治疗急性双相抑郁的前瞻性开放标签研究。

A prospective, open-label study of Aripiprazole mono- and adjunctive treatment in acute bipolar depression.

作者信息

Dunn Robert T, Stan Vanessa A, Chriki Lyvia S, Filkowski Megan M, Ghaemi S Nassir

机构信息

Psychopharmacology Research Program, Cambridge Health Alliance, Cambridge, MA, USA.

出版信息

J Affect Disord. 2008 Sep;110(1-2):70-4. doi: 10.1016/j.jad.2008.01.004. Epub 2008 Feb 12.

DOI:10.1016/j.jad.2008.01.004
PMID:18272230
Abstract

OBJECTIVE

To examine the efficacy and tolerability of aripiprazole treatment for acute bipolar depression.

METHODS

A six-week prospective, nonrandomized, open label study was conducted in depressed bipolar outpatients (types I, II, and NOS), as diagnosed by DSM-IV criteria. Previous treatments were continued unchanged, and new treatments not permitted, except lorazepam up to 2 mg daily. Aripiprazole was dosed flexibly up to a maximum of 30 mg daily, based on tolerability and efficacy. Montgomery-Asberg Depression Rating Scale (MADRS) and Mania Rating Scale (MRS) scores were used to assess changes in mood symptoms. Side effect outcomes were measured. Data was analyzed using last observation carried forward methodology and Analysis of Variance.

RESULTS

Twenty patients (15 men, 5 women) with bipolar disorder (10 type I, 7 type II, 3 type NOS) enrolled in the study. Mean endpoint dose was 13.6 mg/d+/-10.0 mg/d. Thirteen (65%) patients completed 6 weeks of treatment. MADRS and MRS scores significantly improved during treatment. 44% of patients who completed at least one week of treatment were considered responders, based on > or =50% decrease in MADRS scores from baseline. Side effect measures were mostly unchanged during treatment.

CONCLUSION

Depressive symptoms improved in bipolar patients treated with open-label aripiprazole.

摘要

目的

探讨阿立哌唑治疗急性双相抑郁的疗效和耐受性。

方法

对符合DSM-IV标准诊断的双相抑郁门诊患者(I型、II型和未特定型)进行为期六周的前瞻性、非随机、开放标签研究。既往治疗维持不变,除每日最多2mg劳拉西泮外,不允许使用新的治疗方法。根据耐受性和疗效,阿立哌唑剂量灵活调整,最大剂量为每日30mg。使用蒙哥马利-阿斯伯格抑郁评定量表(MADRS)和躁狂评定量表(MRS)评分评估情绪症状变化。测量副作用结果。采用末次观察结转法和方差分析对数据进行分析。

结果

20例双相情感障碍患者(15例男性,5例女性)(10例I型,7例II型,3例未特定型)纳入研究。平均终点剂量为13.6mg/d±10.0mg/d。13例(65%)患者完成了6周治疗。治疗期间MADRS和MRS评分显著改善。根据MADRS评分较基线下降≥50%,44%完成至少一周治疗的患者被视为有效者。治疗期间副作用指标大多未变。

结论

开放标签使用阿立哌唑治疗的双相情感障碍患者抑郁症状改善。

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